C-Path to Host a Scientific Breakthrough Summit Oct. 26-27

Addressing Unmet Regulatory Needs and Drug Development Opportunities through Collaborations in Type 1 Diabetes, Alpha-1 Antitrypsin Deficiency, Lysosomal Disorders, and Vulnerable Populations including Neonates

TUCSON, Ariz., Aug. 17, 2023 – Critical Path Institute (C-Path), a leading nonprofit dedicated to accelerating drug development to advance better treatments for people worldwide, is pleased to announce its upcoming Scientific Breakthrough Summit, October 26 -27, 2023, at the Westin Crystal City, Reagan National Airport, Arlington, Va.

The summit aims to bring together industry experts, global regulatory agencies, academic researchers, clinicians of multiple backgrounds, patients, parents and caregivers to inform a productive dialogue around opportunities to leverage public-private partnerships to accelerate drug development with a focus on vulnerable populations.

“Through the unique neutral environment that C-Path provides, and along with strong participation from regulators, this meeting stands to benefit drug developers across multiple therapeutic areas, as well as individuals with lived experiences, their families and caregivers,” said C-Path Chief Science Officer Klaus Romero, M.D., M.S., FCP.

The objectives of the summit are as follows:

  1. Examine specific drug development needs and proposed solutions with a focus on type 1 diabetes, alpha-1 antitrypsin deficiency, lysosomal disorders and vulnerable populations including neonates. Through in-depth discussions and interactive sessions, participants will explore proposed solutions and identify opportunities for improvement.
  2. Demonstrate the value and impact of data sharing through compelling case studies in specific therapeutic areas and showcase multi-stakeholder collaborations resulting in drug development solutions. Attendees will gain valuable insights into the power of collaboration and the impact it can have on bringing life-changing, novel therapies to those in need.
  3. Determine how potential regulatory and drug development solutions could have applicability to the evolving field of cell and gene-based therapies. Industry leaders, in collaboration with clinical, academic and regulatory experts will discuss the latest developments and identify opportunities to optimize the process to develop innovative and potentially curative therapies. Attendees will gain valuable insights into the future of cell and gene therapies and their potential to revolutionize healthcare.

Attendees will have the opportunity to engage in disease and topic-focused stimulating discussions inclusive of global regulatory agency leaders, network with industry peers and collaborate on cutting-edge research initiatives.

“We are thrilled to host the Scientific Breakthrough Summit, a platform that brings together diverse stakeholders from across the drug development landscape,” said C-Path Director of Pediatric Programs, Kanwaljit Singh, M.D., MPH. “Through this collaborative event, we aim to discuss innovation opportunities for drug development needs in populations with type 1 diabetes, alpha-1 antitrypsin deficiency, lysosomal diseases and neonatal conditions. By fostering multi-stakeholder partnerships and exploring cutting-edge advancements like cell and gene therapies, we hope to advance innovative solutions that can make a positive impact on patients’ lives.”

Registration for the summit is free and open to the public. For more information and to register for the event, please visit https://cvent.me/qdkDgy.


About Critical Path Institute

Critical Path Institute (C-Path) is an independent, nonprofit established in 2005 as a public-private partnership, in response to the FDA’s Critical Path Initiative. C-Path’s mission is to lead collaborations that advance better treatments for people worldwide. Globally recognized as a pioneer in accelerating drug development, C-Path has established numerous international consortia, programs and initiatives that currently include more than 1,600 scientists and representatives from government and regulatory agencies, academia, patient organizations, disease foundations and pharmaceutical and biotech companies. With dedicated team members located throughout the world, C-Path’s global headquarters is located in Tucson, Arizona and C-Path’s Europe subsidiary is headquartered in Amsterdam, Netherlands. For more information, visit c-path.org.

Critical Path Institute is supported by the Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) and is 55% funded by the FDA/HHS, totaling $17,612,250, and 45% funded by non-government source(s), totaling $14,203,111. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.

Kissy Black